Ignite Creation Date:
2024-05-06 @ 1:03 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03917329
Status:
COMPLETED
Last Update Posted:
2020-03-25
First Post:
2018-11-06
Brief Title:
Evaluation of an ACT and PBS Group for Parents and Education Staff
Sponsor:
University of Edinburgh
Organization:
University of Edinburgh
Study Overview
Official Title:
An Evaluation of an ACT and PBS Group for Parents and Education Staff of Children and Young People With an Intellectual Disability
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Parents and education staff who work with children with intellectual disabilities ID are known to be at a higher risk of experiencing psychological distress This study evaluates whether a therapeutic group for parents and education staff who work with children with ID is effective in reducing psychological distress and if so how it does this and who it works for The group will include two components an Acceptance and Commitment Therapy ACT section and a section about positive behaviour support PBS ACT is a psychological therapy the aim of which is to help people to live their lives based on what matters to them whilst learning new ways of managing difficult thoughts and feelings
The PBS section aims to help participants to learn how to use positive strategies to reduce challenging behaviour Both interventions have been shown to be effective on their own but this study will examine if combining the two is helpful Parents of children with ID and education staff who work closely with children with ID attending chosen schools or learning disability child and adolescent mental health services in NHS Lothian will be invited to participate in the study The group will take place on three half days Participants will complete questionnaires on the first and last day of the group and six weeks after it has finished The questionnaires will be about psychological distress confidence in caring for children with ID and seeing if the group changed how they cope with thoughts and feelings Participants will also be invited to a focus group which will think about if the intervention was helpful and if so how it helped If the group is effective the investigators would hope to research the intervention in more depth with the aim of it being offered more widely in the future
The PBS section aims to help participants to learn how to use positive strategies to reduce challenging behaviour Both interventions have been shown to be effective on their own but this study will examine if combining the two is helpful Parents of children with ID and education staff who work closely with children with ID attending chosen schools or learning disability child and adolescent mental health services in NHS Lothian will be invited to participate in the study The group will take place on three half days Participants will complete questionnaires on the first and last day of the group and six weeks after it has finished The questionnaires will be about psychological distress confidence in caring for children with ID and seeing if the group changed how they cope with thoughts and feelings Participants will also be invited to a focus group which will think about if the intervention was helpful and if so how it helped If the group is effective the investigators would hope to research the intervention in more depth with the aim of it being offered more widely in the future
Detailed Description:
Study Design
The study has a mixed methods design The mixed methods approach allows the utilisation both quantitative and qualitative approaches to gain a greater level of detail than either one methodology would allow for individually and for the results to support a firmer conclusion if the differing methodologies corroborate each other
Protocol
The Learning Disability Child and Adolescent Mental Health Service LD-CAMHS service in NHS Lothian National Health Service board located in Scotland and schools for children with special educational needs in the City of Edinburgh Council area will be invited to participate in the study Senior education staff Headteachers or Deputy Headteachers and LD-CAMHS clinicians will be asked to identify potential participants based on the study inclusion and exclusion criteria They will then be asked to provide potential participants with the participant information sheet and discuss this with them inviting potential participants to ask any questions that they may have LD-CAMHS clinicians and education staff are suitable for this role as they are likely to be aware of childrens diagnoses and whether the family have reported that their child presents with challenging behaviour or aware of education staffs role and length of their remaining contract Examples and a definition of challenging behaviour will be provided as a general guide to support the identification of participants Interested potential participants will be given a minimum of 24 hours to consider whether they want to participate
If interested in taking part participants will be asked to complete and return a contact details form to their LD-CAMHS clinician or to senior education staff The research team will contact the clinicians and senior education staff at agreed time intervals eg once a week to see if there are forms to be collected In the contact details form participants will be asked to indicate what time of day suits them best to be contacted Participants will then receive a telephone call from the researcher to answer any questions they may have and to discuss their availability to attend the ACT and PBS group eg would during or after school hours be preferable are there certain days of the week that would suit them best would location be a barrier
Groups will aim to have 10 participants with the expectation that some participants will choose to drop out of the study at this point probably reducing the group size to approximately 6 to 8 participants Participants will be allocated to attend a group based on their participant number whether they are education staff or a parent their location and availability Participants will be sent a letter advising of the dates and location of their allocated group sessions and focus group Should participants contact the researcher to advise that they cannot attend on these dates they will be re-allocated to an alternative group if possible
The ACT and PBS group will take place in a community setting such as an appropriate room in a school or in an NHS building Participants will complete the study consent form with the study researchers on an individual basis before the first group session begins This will provide a further opportunity for participants to ask any questions that they may have and for the study researchers to ensure that participants are fully informed about the study and that they are making an informed decision to participate Participants will then complete a battery of measures at the beginning of the first group session at the end of the third group session and at the beginning of the focus group which will take place six weeks after the last group session Should a participant choose not to take part in the focus group they will be sent a copy of the questionnaires by post and asked to return them by post via a returns envelope provided or to their LD-CAMHS clinician or school
The group workshop will run for three mornings afternoons or evenings over three consecutive weeks eg three Friday mornings The sessions will last for approximately three to three and a half hours with a break and refreshments in between The group sessions will include taking part in exercises such as mindfulness having group discussions learning about new ways of managing difficult thoughts and feelings and learning about new ways of supporting challenging behaviours in a positive way Participants can decide not to take part in a component of the group should they prefer not to Education staff and parents will attend separate groups The group sessions will be facilitated by the study researchers namely a Trainee Clinical Psychologist and Clinical Psychologist who have both completed relevant ACT and PBS teaching and training and have experience in working with these psychological interventions
The focus group will take place approximately six weeks later and will take approximately one hour in a similar setting as the therapy group The group will be facilitated by a researcher who did not facilitate the participants therapy group to increase the likelihood that they will feel able to discuss the group freely This researcher may be a LD-CAMHS clinician The group will be audio-recorded with an NHS Lothian encrypted and password protected audio recorder to allow for the group discussion to be transcribed and analysed Participants who do not attend one or more of the group sessions will be welcome to attend the remaining sessions if they so wish but will be excluded from any relevant analyses Participants may take part in the focus group if they have attended at least one group session
Number of Participants
The investigators will aim to recruit approximately 40 participants to the study 10 participants allocated to four groups
Number of sites involved The investigators anticipate that there will be 8 LD-CAMHS and up to 7 schools for children with special educational needs
Length of recruitment period Estimated at approximately six to eight months
Sample Size Calculation
Power calculations were performed utilising G-Power 31 The statistical analysis was set to be a with a within-between interaction with two groups and three measurement points The alpha level was set to 005 and power to 080 as per convention The effect size previously reported for psychological distress in a similar study was medium to large To be conservative the power calculation for this study was performed with a medium effect size f025 which suggested a total sample size of 28 participants Therefore this study will aim to have four groups with ten participants each This would mean recruiting 40 participants with the expectation that 12 would be lost to attrition
Proposed Analyses
The mean standard deviation and range of the demographic variables and dependent variables will be reported The percentage of missing data across the measures will also be reported
Regarding quantitative data the statistical analysis will be completed using SPSS software Data will be explored to ensure that test assumptions are met Each dependent variable will then be analysed with repeated measures analyses of variance ANOVA with a within-between interaction with significant effects further evaluated appropriately
Regarding qualitative data the focus group interview transcripts will be analysed with thematic analysis
Management of Missing Data
Should the level of missing data be minimal 5 the data will be assumed to be missing at random and a suitable method of imputation most likely multiple imputation due to the small sample size will be used to manage this appropriately Should a higher level of missing data occur the missing data will be analysed to examine whether it is missing at random or not A suitable method of imputation will then be used
Adverse Events
Should multiple participants present with high levels of persistent distress that appear to be related to participating in the group this will be reviewed by the Chief investigator and researchers
The study has a mixed methods design The mixed methods approach allows the utilisation both quantitative and qualitative approaches to gain a greater level of detail than either one methodology would allow for individually and for the results to support a firmer conclusion if the differing methodologies corroborate each other
Protocol
The Learning Disability Child and Adolescent Mental Health Service LD-CAMHS service in NHS Lothian National Health Service board located in Scotland and schools for children with special educational needs in the City of Edinburgh Council area will be invited to participate in the study Senior education staff Headteachers or Deputy Headteachers and LD-CAMHS clinicians will be asked to identify potential participants based on the study inclusion and exclusion criteria They will then be asked to provide potential participants with the participant information sheet and discuss this with them inviting potential participants to ask any questions that they may have LD-CAMHS clinicians and education staff are suitable for this role as they are likely to be aware of childrens diagnoses and whether the family have reported that their child presents with challenging behaviour or aware of education staffs role and length of their remaining contract Examples and a definition of challenging behaviour will be provided as a general guide to support the identification of participants Interested potential participants will be given a minimum of 24 hours to consider whether they want to participate
If interested in taking part participants will be asked to complete and return a contact details form to their LD-CAMHS clinician or to senior education staff The research team will contact the clinicians and senior education staff at agreed time intervals eg once a week to see if there are forms to be collected In the contact details form participants will be asked to indicate what time of day suits them best to be contacted Participants will then receive a telephone call from the researcher to answer any questions they may have and to discuss their availability to attend the ACT and PBS group eg would during or after school hours be preferable are there certain days of the week that would suit them best would location be a barrier
Groups will aim to have 10 participants with the expectation that some participants will choose to drop out of the study at this point probably reducing the group size to approximately 6 to 8 participants Participants will be allocated to attend a group based on their participant number whether they are education staff or a parent their location and availability Participants will be sent a letter advising of the dates and location of their allocated group sessions and focus group Should participants contact the researcher to advise that they cannot attend on these dates they will be re-allocated to an alternative group if possible
The ACT and PBS group will take place in a community setting such as an appropriate room in a school or in an NHS building Participants will complete the study consent form with the study researchers on an individual basis before the first group session begins This will provide a further opportunity for participants to ask any questions that they may have and for the study researchers to ensure that participants are fully informed about the study and that they are making an informed decision to participate Participants will then complete a battery of measures at the beginning of the first group session at the end of the third group session and at the beginning of the focus group which will take place six weeks after the last group session Should a participant choose not to take part in the focus group they will be sent a copy of the questionnaires by post and asked to return them by post via a returns envelope provided or to their LD-CAMHS clinician or school
The group workshop will run for three mornings afternoons or evenings over three consecutive weeks eg three Friday mornings The sessions will last for approximately three to three and a half hours with a break and refreshments in between The group sessions will include taking part in exercises such as mindfulness having group discussions learning about new ways of managing difficult thoughts and feelings and learning about new ways of supporting challenging behaviours in a positive way Participants can decide not to take part in a component of the group should they prefer not to Education staff and parents will attend separate groups The group sessions will be facilitated by the study researchers namely a Trainee Clinical Psychologist and Clinical Psychologist who have both completed relevant ACT and PBS teaching and training and have experience in working with these psychological interventions
The focus group will take place approximately six weeks later and will take approximately one hour in a similar setting as the therapy group The group will be facilitated by a researcher who did not facilitate the participants therapy group to increase the likelihood that they will feel able to discuss the group freely This researcher may be a LD-CAMHS clinician The group will be audio-recorded with an NHS Lothian encrypted and password protected audio recorder to allow for the group discussion to be transcribed and analysed Participants who do not attend one or more of the group sessions will be welcome to attend the remaining sessions if they so wish but will be excluded from any relevant analyses Participants may take part in the focus group if they have attended at least one group session
Number of Participants
The investigators will aim to recruit approximately 40 participants to the study 10 participants allocated to four groups
Number of sites involved The investigators anticipate that there will be 8 LD-CAMHS and up to 7 schools for children with special educational needs
Length of recruitment period Estimated at approximately six to eight months
Sample Size Calculation
Power calculations were performed utilising G-Power 31 The statistical analysis was set to be a with a within-between interaction with two groups and three measurement points The alpha level was set to 005 and power to 080 as per convention The effect size previously reported for psychological distress in a similar study was medium to large To be conservative the power calculation for this study was performed with a medium effect size f025 which suggested a total sample size of 28 participants Therefore this study will aim to have four groups with ten participants each This would mean recruiting 40 participants with the expectation that 12 would be lost to attrition
Proposed Analyses
The mean standard deviation and range of the demographic variables and dependent variables will be reported The percentage of missing data across the measures will also be reported
Regarding quantitative data the statistical analysis will be completed using SPSS software Data will be explored to ensure that test assumptions are met Each dependent variable will then be analysed with repeated measures analyses of variance ANOVA with a within-between interaction with significant effects further evaluated appropriately
Regarding qualitative data the focus group interview transcripts will be analysed with thematic analysis
Management of Missing Data
Should the level of missing data be minimal 5 the data will be assumed to be missing at random and a suitable method of imputation most likely multiple imputation due to the small sample size will be used to manage this appropriately Should a higher level of missing data occur the missing data will be analysed to examine whether it is missing at random or not A suitable method of imputation will then be used
Adverse Events
Should multiple participants present with high levels of persistent distress that appear to be related to participating in the group this will be reviewed by the Chief investigator and researchers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None